MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	44021
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.Percutaneous transluminal angioplasty (pta) was performed.An opticross 18 was selected for use.However, it was noted that the tip broke.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that tip detachment occurred.Percutaneous transluminal angioplasty (pta) was performed.An opticross 18 was selected for use.However, it was noted that the tip broke.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the distal tip or guidewire exit port assembly appears to be damaged.A kink was observed in the sheath assembly from the femoral marker to the distal end and a kink was observed in the telescope assembly from the femoral marker to the proximal end.No detachment was observed during the testing process.A test guidewire was inserted and no indication of resistance in tracking the guidewire into of the catheter was noted.No other issues or defects were observed during product analysis of the returned device.

• Brand Name: OPTICROSS 18
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8957477
• Report Number: 2134265-2019-10208
• Device Sequence Number: 11287614
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: 08714729904748
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K160514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0022175660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/03/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR