MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the ostial circumflex artery.After a guide wire was advanced, a 2.00mm x 8mm emerge balloon catheter was advanced for dilatation.However, upon loading the device on the wire, it was noted that the balloon was fractured.The device did not enter the patient's body.The procedure was completed with a different device.No patient harm nor complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the ostial circumflex artery.After a guide wire was advanced, a 2.00mm x 8mm emerge balloon catheter was advanced for dilatation.However, upon loading the device on the wire, it was noted that the balloon was fractured.The device did not enter the patient's body.The procedure was completed with a different device.No patient harm nor complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed damage to the tip.There is buckling on the guidewire lumen 12mm and 13mm from the tip.There is blood present in the guidewire lumen.The balloon was loosely folded prior to inflation testing.Since the reported complaint was for fracture the device was inflated to find any possible leaks.Per product specification, the balloon was inflated to rated burst pressure and could hold pressure for 5 minutes.No leaks were found.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8414014
• Report Number: 2134265-2019-02316
• Device Sequence Number: 303340
• Product Code: LOX
• UDI-Device Identifier: 08714729806509
• UDI-Public: 08714729806509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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): 04/25/2019

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: 08/10/2021
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 23083181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 100