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

Model Number H7493918915250

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The balloon was tightly folded.There was contrast in the inflation lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube shaft was completely separated 70 cm from the tip.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on 21-apr-2016.It was reported that shaft kink occurred.A 2.50mm x 15mm emerge¿ balloon catheter was selected to dilate the lesion.However during preparation, the shaft was kinked.The device was not used and the procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a hypotube break 70cm from the tip.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6555798
• MDR Text Key: 74792934
• Report Number: 2134265-2017-04451
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: H7493918915250
• Device Catalogue Number: 39189-1525
• Device Lot Number: 20256152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2017
• Initial Date FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1