MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 1997-10-15 for STARGATE FALLOPOSCOPY CATHETER RMSBES0007 NA manufactured by Conceptus, Inc..
[72608]
Adverse event: the stargate falloposcopy catheter perorated the fimbrial section of the fallopian tube during a falloposcopy procedure. This is an anticipated adverse event as indicated in the product labeling. The physician said that no medical intervention was required to resolve the adverse event and that there were no immediate clinical sequelae. The adverse event is marked "other" because it is unk as to whether the adverse event will result in permanent impairment of body function or permanent damage to body structure. Correction made 10/30/97.
Patient Sequence No: 1, Text Type: D, B5
[7827345]
Event: the stargate falloposcopy catheter (lot #rd9715301) was used in a falloposcopy procedure in victoria, australia on sept 16, 1997. The device is mfg with a diamond shaped wire tip. The tip is attached to the catheter with four wires that are embedded into the catheter shaft. The device user, a physician, reported that during the procedure there was a partial dislodgment of the wires from the catheter shaft. This was visualized laparoscopically after the catheter had perforated the fimbrial section of the fallopian tube. With laparoscopic scissors, the physician chose to cut off the entire wire tip from the catheter shaft and retrieve it through the laparoscopic port. The device was returned to the co for evaluation. Evaluation: the device was visually inspected and dislodgment of two of the four wires was confirmed. Pull force test data for the wire tip was also evaluated. The pull force data from this lot exceeded the release specification and was in the same range of pull force data from seven other lots, for which no such events have been reported. A sample of sterilized catheters from eight lots, including lot #rd9715301, was also tested to determine if pull forces may have been compromised after sterilization (the original testing was doen pre-sterilization). This data additionally demonstrated that the pull forces from all lots exceeded the specification. The data from lot #rd9715301 was also in the same range of pull force data as compared to the seven other lots. Conclusion: based on the pull force evaluation, the cause of the dislodgment was determined to be unk. During discussions with the physician regarding procedure details, co reported that during fallopian tube catheterization, the fallopian tube had slipped through laparoscopic forceps and fallen into an area of adhesions in the peritoneal cavity. Co additionally reported that it had been difficult to retrieve and grasp the fallopian tube with laparoscopic forceps to bring it out of the adhesions and back into the field of view. It was durign this time that the fallopian tube could not be laparoscopically visualized, that the catheter perforated the tube, leaving the wire tip exposed in the peritoneal cavity yet hidden in the adhesions. The co concluded that the laparoscopic forceps may have accidentally grasped the wire tip while the physician was trying to grasp the fallopian tube. These type of forces would exceed the pull forces normally expected during clinical use of the device. Although this conclusion could not be corroborated by the physician, the co decided to add a warning to the product labeling stating that the device should not be grasped with laparoscopic forceps.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951250-1997-00004 |
| MDR Report Key | 127464 |
| Report Source | 01,05,06 |
| Date Received | 1997-10-15 |
| Date of Report | 1997-10-14 |
| Date of Event | 1997-09-16 |
| Date Mfgr Received | 1997-09-16 |
| Device Manufacturer Date | 1997-07-01 |
| Date Added to Maude | 1997-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STARGATE FALLOPOSCOPY CATHETER |
| Generic Name | FALLOPIAN TUBE CATHETER |
| Product Code | MKO |
| Date Received | 1997-10-15 |
| Returned To Mfg | 1997-09-23 |
| Model Number | RMSBES0007 |
| Catalog Number | NA |
| Lot Number | RD9715301 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 124719 |
| Manufacturer | CONCEPTUS, INC. |
| Manufacturer Address | 1021 HOWARD AVENUE SAN CARLOS CA 94070 US |
| Baseline Brand Name | STARGATE PENI FALLOPOSCOPY CATHETER |
| Baseline Generic Name | FALLOPIAN TUBE CATHETER |
| Baseline Model No | RMSBES0007 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-10-15 |