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

Model Number H7493895912270

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft perforation occurred.A 2.75mmx12mm apex¿ balloon catheter was advanced for dilatation.However, a difficulty in loading the balloon catheter over the wire was encountered.A stylet was then able to load onto the wire and the device was then finally loaded over the wire.After the device was advanced and was attempted to be inflated however, the balloon failed to inflate.When the balloon was taken out from the patient, it was noticed that there was a hole in the shaft where pressure was coming out.The procedure was completed with a different device.No patient complications were reported and the patient's status was okay.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an apex mr balloon catheter.The balloon was loosely folded, and there was blood in the wire lumen.The tip, balloon, inner shaft, outer shaft, port/exit notch, and hypotube were microscopically and tactile inspected.Inspection revealed damage (perforation) to the underside of the port/exit notch (23.5cm from tip) and a kink in the hypotube 16 cm from the strain relief.Functional testing was done with a lab supplied.014¿ guide wire.The wire loaded fine, but became caught at the area of the port/exit notch damage.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that shaft perforation occurred.A 2.75mmx12mm apex¿ balloon catheter was advanced for dilatation.However, a difficulty in loading the balloon catheter over the wire was encountered.A stylet was then able to load onto the wire and the device was then finally loaded over the wire.After the device was advanced and was attempted to be inflated however, the balloon failed to inflate.When the balloon was taken out from the patient, it was noticed that there was a hole in the shaft where pressure was coming out.The procedure was completed with a different device.No patient complications were reported and the patient's status was okay.

• Brand Name: APEX¿
• 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: 6066018
• MDR Text Key: 58720960
• Report Number: 2134265-2016-09658
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• 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,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: H7493895912270
• Device Catalogue Number: 38959-1227
• Device Lot Number: 18897319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• 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