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

Model Number	U357566
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Retraction Problem (1536)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11892739
• Report Number: 2020394-2021-01120
• Device Sequence Number: 11689924
• Product Code: LIT
• UDI-Device Identifier: 00801741092961
• UDI-Public: (01)00801741092961
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/05/2021; 10/05/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 07/22/2021; 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention