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

Model Number H7493912408300

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex¿ balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, shaft and tip were microscopically and tactile inspected.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination revealed that the shaft had a hole on the back side of the exit notch with deep scratches.The damage to the shaft is consistent with damage that occurs due to interaction with the guidewire.The tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter.The balloon, shaft and tip were microscopically and tactile inspected.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic examination revealed that the shaft had a hole on the back side of the exit notch with deep scratches.The damage to the shaft is consistent with damage that occurs due to interaction with the guidewire.The tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that shaft hole occurred.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilation.Inflation was attempted at 12 atmospheres, however, the balloon did not inflate.The device was removed and a hole on the shaft was noted, where the contrast media leaked.The procedure was completed with another 3.0x8mm nc balloon catheter.No patient complications were reported.

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7654752
• MDR Text Key: 112872292
• Report Number: 2134265-2018-05677
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2020
• Device Model Number: H7493912408300
• Device Catalogue Number: 39124-0830
• Device Lot Number: 21394941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1