MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number U357566

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 07/2023.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate and needle stick used to deflate the balloon.It was further reported that balloon allegedly had difficult to remove form sheath.Patient reported stable.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate and needle stick used to deflate the balloon.It was further reported that balloon allegedly was difficult to remove from the sheath.There was no patient injury.

Event Description

It was reported that during an angioplasty procedure, the pta balloon allegedly failed to deflate and needle stick used to deflate the balloon.It was further reported that balloon allegedly was difficult to remove from the sheath.There was no patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 035 pta dilatation catheter loaded with an unknown 7fr sheath has been received for the evaluation.On the visual evaluation, the device appeared bloody.The distal tip of the sheath was noted to be buckled with the distal end of the balloon exposed and partially deflated.No other anomalies were noted.No other functional testing was performed.Therefore the investigation for the reported difficult to remove is confirmed as the distal end of the balloon was stucked at the distal tip of the sheath.The investigation for the reported deflation problem remains inconclusive as the functional testing was not performed due to condition of the device returned.A definitive root cause for the alleged deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: ULTRAVERSE 035 PTA CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11892739
• MDR Text Key: 252899140
• Report Number: 2020394-2021-01120
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092961
• UDI-Public: (01)00801741092961
• Combination Product (y/n): N
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U357566
• Device Catalogue Number: U357566
• Device Lot Number: CMEV0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 07/05/2021; 10/05/2021
• Supplement Dates FDA Received: 07/22/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention