MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895908200
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the ramus artery.After a guide wire crossed the lesion, a 2.00 mm x 8 mm apex¿ balloon catheter was advanced but failed to cross the lesion.The physician then removed the wire and the balloon; however, it was noted under fluoroscopy that the balloon was still in the artery while the balloon shaft was out of the patient's body.Subsequently, a snare was used and the balloon was successfully removed form the patient's body.No further complications were reported and the patient was discharged home the next day.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The tip, part of the balloon and part of the inner shaft was disposed of by the customer.The balloon, proximal bond, port/exit notch, inner shaft and outer shaft were microscopically examined.Inspection revealed the balloon had separated and only 8mm of the balloon was returned, there were numerous kinks in the hypotube, the inner shaft was damaged (focally stretched) near the bicomponent weld, and the inner shaft separated approximately 2mm proximal to the proximal bond.Inspection of the remainder of the device revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the ramus artery.After a guide wire crossed the lesion, a 2.00mm x 8mm apex¿ balloon catheter was advanced but failed to cross the lesion.The physician then removed the wire and the balloon; however, it was noted under fluoroscopy that the balloon was still in the artery while the balloon shaft was out of the patient's body.Subsequently, a snare was used and the balloon was successfully removed form the patient's body.No further complications were reported and the patient was discharged home the next day.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6705973
• Report Number: 2134265-2017-06729
• Device Sequence Number: 19073638
• Product Code: LOX
• UDI-Device Identifier: 08714729475361
• UDI-Public: (01)08714729475361(17)20200229(10)20348577
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: H7493895908200
• Device Catalogue Number: 38959-0820
• Device Lot Number: 20348577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 07/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR