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

Model Number	7136
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 92% stenosed target lesion was located in the middle and distal end of the left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was selected for use.However, during advancing for the second time, the middle of the delivery shaft was fractured (more then 15 cm from the hub).The device was directly and completely removed from the patient without any intervention and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that shaft break occurred.The 92% stenosed target lesion was located in the middle and distal end of the left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was selected for use.However, during advancing for the second time, the middle of the delivery shaft was fractured (more then 15 cm from the hub).The device was directly and completely removed from the patient without any intervention and the procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.:the returned product consisted of an emerge balloon catheter.The balloon was loosely folded with contrast in the balloon.The hypotube was separated 65.5cm from hub.The hypotube faces were ovaled indicating the hypotube was kinked prior to separating.There also were numerous kinks throughout the catheter.The reported separation was confirmed.

• Brand Name: EMERGE PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9106271
• Report Number: 2134265-2019-11028
• Device Sequence Number: 2062580
• Product Code: LOX
• UDI-Device Identifier: 08714729806042
• UDI-Public: 08714729806042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• 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,Followup
• Report Date (Section B): 10/31/2019

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: 07/24/2021
• Device Model Number: 7136
• Device Catalogue Number: 7136
• Device Lot Number: 0022992360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 48