MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3854
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter broke and the patient was sent to surgery.The target lesion was located in the left anterior descending artery.A 10 mm x 3.00 mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was advanced and inflated just distal to an unknown, previously placed 5yr old stent.After deflation, several attempts were made to remove the device through the stent but were unsuccessful.Subsequently, after continuing to pull, the delivery catheter broke free from the balloon segment inside the lesion.Several attempts to snare the balloon were made but failed.Consequently, the patient was sent for surgery and the device fragment was eventually removed.No further complications were reported and patient was stable post-surgery.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination could not be performed on balloon, markerbands, tip or blades due to the condition of the returned device.A visual and tactile examination found that the hypotube shaft was broken and the manifold/hub section missing (not returned for analysis).Multiple hypotube kinks were also observed along the remaining portion of the shaft.The type of damages noted are consistent with excessive force that could have been applied on the delivery system.A visual examination of the extrusion shaft found that the whole extrusion shaft was detached from the delivery system and damaged the whole length (twisted, stretched and kinked).This type of damage most likely occurred during the several unsuccessful attempts that were made during the procedure to snare the balloon and the extrusion shaft from the patient's body.No issues were identified during the product analysis.
Event or Problem Description
It was reported that the catheter broke and the patient was sent to surgery.The target lesion was located in the left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was advanced and inflated just distal to an unknown, previously placed 5yr old stent.After deflation, several attempts were made to remove the device through the stent but were unsuccessful.Subsequently, after continuing to pull, the delivery catheter broke free from the balloon segment inside the lesion.Several attempts to snare the balloon were made but failed.Consequently, the patient was sent for surgery and the device fragment was eventually removed.No further complications were reported and patient was stable post-surgery.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9146965
• Report Number: 2134265-2019-11844
• Device Sequence Number: 2752797
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• 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): 12/02/2019

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: 07/05/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024064675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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