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

Model Number H7493919312250

Device Problems Deflation Problem (1149); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon deflation failure occurred.During preparation of a 2.50mm x 12mm emerge¿ balloon catheter, the balloon failed to deflate after three attempts.The device was removed from the sterile scrub trolley and double bagged.The device was not used inside the patient and the procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.Functional testing using an inflation device was used to inflate the balloon.The balloon inflated quickly, the device held pressure and was deflated within specification.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that balloon deflation failure occurred.During preparation of a 2.50mm x 12mm emerge balloon catheter, the balloon failed to deflate after three attempts.The device was removed from the sterile scrub trolley and double bagged.The device was not used inside the patient and the procedure was completed with another of the same device.No patient complications were reported.

• 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: 7546327
• MDR Text Key: 109316532
• Report Number: 2134265-2018-04808
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

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: 10/23/2020
• Device Model Number: H7493919312250
• Device Catalogue Number: 39193-1225
• Device Lot Number: 21789449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/10/2018
• Supplement Dates FDA Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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