MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-10-29 for AORTIC VALVULOPLASTY BAL DIL CATH 2622 manufactured by Scimed Life Sytems A Div. Of Boston Scientific, Corp..
[33077]
A balloon burst during an aortic valvuloplasty procedure and began to separate from the catheter shaft. The balloon catheter and introducer sheath were removed as a unit without incident. A second balloon catheter was used to successfully complete the procedure with no pt complications. This device is currently being investigated by co's engineers. Upon completion of the engineering evaluation, a supplemental medwatch form will be forwarded under the above noted sequence number. Co's directions for use state: "if a balloon ruptures while in use and resistance is felt when withdrawing it through a sheath, then the sheath and balloon should be removed together. "
Patient Sequence No: 1, Text Type: D, B5
[7760691]
F11. Date mfr initially forwarded report to fda. H3. Evaluation summary: this device was returned, evaluated and retained by this mfr. The engineering evaluation indicated the shaft was cut 13. 7 centimeters from the distal tip. The remainder of the shaft was not returned. The balloon exhibited a longitudinal burst starting at one centimeter from the distal end of the proximal radiopaque marker to 1. 4 centimeters proximal to the distal radiopaque marker. At the proximal and distal ends of the material there were 5 millimeter circumferential tears all balloon material appeared to be present. Follow up indicated the catheter shaft was cut after teh procedure was complete. Without being able to examine the entire device, a thoruough evaluation could not be performed. Therefore co cannot determine the exact cause for this event. H6. 86/other - microscopic evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220076-1996-00010 |
| MDR Report Key | 46044 |
| Report Source | 05 |
| Date Received | 1996-10-29 |
| Date of Report | 1996-10-01 |
| Date of Event | 1996-09-25 |
| Date Reported to FDA | 1997-10-29 |
| Date Mfgr Received | 1996-10-01 |
| Date Added to Maude | 1996-11-05 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AORTIC VALVULOPLASTY BAL DIL CATH |
| Generic Name | AORTIC VALVULOPLASTY BAL |
| Product Code | MAD |
| Date Received | 1996-10-29 |
| Model Number | NA |
| Catalog Number | 2622 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46894 |
| Manufacturer | SCIMED LIFE SYTEMS A DIV. OF BOSTON SCIENTIFIC, CORP. |
| Manufacturer Address | 135 FORBES BLVD MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-29 |