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

Catalog Number ATG80144

Device Problems Loss of or Failure to Bond (1068); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that at the conclusion of a successful angioplasty procedure in the subclavian vein, the pta balloon allegedly got stuck inside the 7fr sheath during retraction.Reportedly, the balloon and sheath were removed as one unit.The subclavian vein was reported to be patent with good blood flow post angioplasty.Hemostasis was obtained using a purse string suture at the access site.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not performed as the lot number was not provided.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 14mm x 4cm balloon.The balloon was received within the customer's introducer sheath.The balloon was observed to be completely pulled out from the outer shaft, indicating a loss in the weld bond at the proximal neck.The entire device remained in one piece.The inflation/deflation holes on the shaft, as well as the glue bullet on the polyimide, were visible outside of the balloon.The distal end of the balloon had been pulled proximally, resulting in the balloon being partially prolapsed over itself.The condition of the returned device likely indicates that the user observed retraction issues during the event.The weld bond was examined under microscopic magnification and evidence of material transfer between the balloon and the catheter shaft was observed, indicating that the laser welding had melted the two components together.The weld bond appeared to be consistent around the entire circumference of the bond, with no defects noted.The sheath was examined under microscopic magnification and the distal tip of the sheath was flared in appearance, likely indicating retraction issues.Functional/performance evaluation: due to the poor sample condition, further functional testing was not performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.Based on the condition in which the sample was received, the investigation is confirmed for sheath related retraction issues and loss of bond at the proximal weld bond.It is likely the retraction issues led to the loss of bond.However, the definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported 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.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.Do not continue to use the balloon catheter if the shaft has been bent or kinked.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that at the conclusion of a successful angioplasty procedure in the subclavian vein, the pta balloon allegedly got stuck inside the 7fr sheath during retraction.Reportedly, the balloon and sheath were removed as one unit.The subclavian vein was reported to be patent with good blood flow post angioplasty.Hemostasis was obtained using a purse string suture at the access site.There was no reported patient injury.

• Brand Name: ATLAS GOLD PTA BALLOON DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• 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: 6191486
• MDR Text Key: 62912201
• Report Number: 2020394-2016-01188
• Device Sequence Number: 1
• Product Code: DQY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

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 Catalogue Number: ATG80144
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 66 YR
• Patient Weight: 60