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

Model Number	7134
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned complaint device consisted of an emerge balloon catheter.The balloon was loosely folded.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 72cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There were numerous hypotube and shaft kinks along the device.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that could have contributed to the reported event.
Event or Problem Description
Reportable based on device analysis completed on 26-jul-2020.It was reported that shaft kink occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, it was noted that the delivery shaft was kinked.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• 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: 10421208
• Report Number: 2134265-2020-11286
• Device Sequence Number: 3872486
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 04/17/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0024300699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 69