MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for OPTICROSS 8655 manufactured by Boston Scientific Corporation.
[183178040]
There was no damage observed on the distal tip or guidewire exit port assembly. A detachment was found in the imaging window from the lapjoint. A kink was observed in the telescope assembly from the femoral marker to the proximal end. In order to inspect for imaging core windup at the proximal end of the catheter, the hub rotator retainer clip was removed. The rotator and imaging core assembly was pulled out from hub. No ic windup was found within the telescope section and the sheath section of the device. No other visual damages were encountered upon visual inspection. The mdu and ilab system were used to perform a functional inspection on the device along with the above referenced calibrated equipment impedance testing shows an electrical open at proximal wave form. The image testing cannot be preformed due to the condition of the device. A microscopic inspection identified that the distal housing and the transducer assembly appears to be in good condition, a lap joint detachment was found. The lapjoint section was within specification based on the drawing. The complaint device was sent for x-ray analysis to further characterize the electrical failure. Based on the x-ray images, the electrical failure was a result of a broken coax cable.
Patient Sequence No: 1, Text Type: N, H10
[183178041]
Reportable based on device analysis completed on 21feb2020. It was reported that poor image occurred. A percutaneous coronary intervention was being performed. The 95% stenosed, 12mm in length, 3. 0mm vessel diameter, target lesion was located in the mildly tortuous and severely calcified left anterior descending artery. An opticross ic was selected for use to view the target lesion. However, during procedure, the catheter could not show a clear image. The physician did not use a pre-dilation balloon to pre-dilate the lesion. The procedure was completed with another of the same device. There were no patient complications reported and patient's condition is stable. However, returned device analysis revealed a lapjoint detachment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03118 |
| MDR Report Key | 9824976 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 2546 CALLE PRIMERA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTICROSS |
| Generic Name | CATHETER, ULTRASOUND, INTRAVASCULAR |
| Product Code | OBJ |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-01-23 |
| Model Number | 8655 |
| Catalog Number | 8655 |
| Lot Number | 0023233746 |
| Device Expiration Date | 2020-01-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |