MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Catalog Number	VA5054
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.The lot number for the device was not provided; therefore, 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 or Problem Description
It was reported that during an angioplasty procedure, the distal tip of pta balloon was allegedly a different shape.It was further reported that there was difficulty retracting the balloon through the 5fr sheath.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
A manufacturing review was not performed as the lot number was not provided.Investigation summary: the device was returned for evaluation.A visual inspection of the returned distal tip found the tip to be slightly tapered at the distal end.However, the taper was uniform around the entire circumference of the tip; no cracks, splits or visual defects were identified on the tip.The investigation is unconfirmed for the reported shape issue of the distal tip, as the distal tip passed all visual requirements.The device was inserted through an in-house 6f introducer sheath, and was able to be inflated and deflated and withdrawn without issue.Therefore, the investigation is unconfirmed for the reported retraction issue.Per the reported event details, the user was allegedly retracting the device from a 5fr sheath.The current instructions for use (ifu) states, "the minimal acceptable sheath french size is printed on the package label.Do not attempt to pass the pta catheter through a smaller size sheath introducer than indicated on the label." this device is labeled for use in a 6fr sheath.It is possible that this was the cause for the reported sheath retraction issues.However, the definitive root cause for the reported issues could not be determined based on the available information.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, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that during an angioplasty procedure, the distal tip of pta balloon was allegedly a different shape.It was further reported that there was difficulty retracting the balloon through the 5fr sheath.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
A manufacturing review was not performed as the lot number was not provided.Investigation summary: the device and seven electronic photos were provided for evaluation.A visual inspection of the returned distal tip found the tip to be slightly tapered at the distal end.However, the taper was uniform around the entire circumference of the tip; no cracks, splits or visual defects were identified on the tip.The investigation is unconfirmed for the reported shape issue of the distal tip, as the distal tip passed all visual requirements.The device was inserted through an in-house 6f introducer sheath, and was able to be inflated and deflated and withdrawn without issue.Therefore, based on the returned samples and photo review, the investigation is unconfirmed for the reported retraction issue.Per the reported event details, the user was allegedly retracting the device from a 5fr sheath.The current instructions for use (ifu) states, "the minimal acceptable sheath french size is printed on the package label.Do not attempt to pass the pta catheter through a smaller size sheath introducer than indicated on the label." this device is labeled for use in a 6fr sheath.It is possible that this was the cause for the reported sheath retraction issues.However, the definitive root cause for the reported issues could not be determined based on the available information.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, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Potential adverse reactions: additional intervention.
Event or Problem Description
It was reported that during an angioplasty procedure, the distal tip of pta balloon was allegedly a different shape.It was further reported that there was difficulty retracting the balloon through the 5fr sheath.Another balloon was used to complete the procedure.There was no reported patient injury.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7343554
• Report Number: 2020394-2018-00238
• Device Sequence Number: 11094215
• Product Code: DQY
• UDI-Device Identifier: 00801741059636
• UDI-Public: (01)00801741059636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: VA5054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/18/2018
• Supplement Date Received by Manufacturer: 04/03/2018; 05/22/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/09/2018; 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1