MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number ATG120164

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Conclusion: the device and the original introducer sheath were returned. A visual inspection found the proximal end of the balloon to be detached from the catheter shaft. The partially detached balloon was prolapsed over the distal tip. Upon further examination of the introducer sheath distal tip, the tip was found to be damaged and flared, indicating retraction issues through the sheath. Therefore the investigation is confirmed for the reported balloon detachment, and for sheath-related retraction issues. Additionally, the investigation is confirmed for dislodged marker bands, as both marker bands were found to have dislodged distally on the inner guidewire lumen. It is possible that the retraction issues led to the inverted balloon, stretched inner lumen, and balloon detachment. However, the definitive root cause for the reported or identified issues could not be determined based upon available information. It is unknown whether patient and/or procedural issues contributed to the event. Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or balloon separation. Do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. If resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. Use of the atlas gold pta dilation catheter: apply negative pressure to fully evacuate fluid from the balloon. Confirm that the balloon is fully deflated under fluoroscopy. While maintaining negative pressure and the position of the guidewire, withdraw the deflated dilatation catheter over-the-wire through the introducer sheath. Use of a gentle clockwise motion may be used to help facilitate catheter removal through the introducer sheath.

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly detached from the catheter shaft. There was no patient injury reported.

Manufacturer Narrative

No hospital/medical records have been made available to the manufacturer. However, photos of the balloon segment have been provided. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure in the iliac vein, the pta balloon allegedly detached from the catheter shaft. There was no patient injury reported.

• Brand Name: ATLAS GOLD PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6817394
• MDR Text Key: 252415844
• Report Number: 2020394-2017-01014
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/23/2020
• Device Catalogue Number: ATG120164
• Device Lot Number: 93TB0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial