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

Catalog Number U3575515

Device Problems Deflation Problem (1149); Kinked (1339); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.Photo's of the original device were provided.The lot number for the device was provided.The device history records are currently under review.The device has been returned to the manufacturer for evaluation.The investigation is currently under way.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 during an angioplasty procedure in the femoral artery the pta balloon allegedly could not be deflated after the first inflation.Reportedly, the balloon and sheath were removed as a single unit.Manual pressure at the incision site and compressing dressing was used to complete the procedure.There was no report of patient injury.

Manufacturer Narrative

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.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 5mm x 150mm balloon.A circumferential balloon rupture was present 68.9cm from the strain relief.The distal portion of the balloon was still attached to the catheter and was extending past the distal end of the sheath.The balloon was bunched in appearance, likely indicating retraction issues.The balloon rupture was examined under microscopic magnification (10x) and the edges were jagged.The inner guidewire lumen was stretched at the location of the rupture.Kinks were observed to the device across the length of the catheter.No kinks were reported by the user.No other anomalies were noted to the device at this time.The introducer sheath tip was examined under microscopic magnification (10x) and was observed to be flared, likely indicating retraction issues.Additionally, the proximal portion of the sheath was bunched in appearance, likely indicating retraction issues.Functional/performance evaluation: functional testing could not be performed due to the condition in which the sample was received.Medical records review: medical records were not provided; therefore, a review could not be performed.Photo review: six electronic photos were reviewed.The photos show the distal end of an ultraverse 035 pta catheter extending out of an introducer sheath.The sample is noted as bloody.The distal tip of the balloon can be identified as bunched, likely indicating retraction issues.A flared sheath tip and bunching on the proximal end of the sheath near the hub of the introducer can be identified, likely indicating retraction issues.Additionally, a circumferential rupture and a kinked catheter can be identified.Based on the photos provided, the investigation is confirmed for sheath related retraction issues, kinked catheter and a circumferential balloon rupture.Conclusion: the device was returned within a 5fr introducer sheath and six electronic photos were returned for review.Based on the condition of the returned sample and the photo review, the investigation is confirmed for a circumferential balloon rupture, retractions issues, and a kinked catheter.The investigation is inconclusive for deflation issues, as functional evaluation could not be performed due to poor sample condition.The definitive root cause 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: 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 still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter s a single unit.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention (b)(4).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 during an angioplasty procedure in the femoral artery the pta balloon allegedly could not be deflated after the first inflation.Reportedly, the balloon and sheath were removed as a single unit.Manual pressure at the incision site and compressing dressing was used to complete the procedure.There was no report of patient injury.

• Brand Name: ULTRAVERSE 035 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): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6251324
• MDR Text Key: 64900391
• Report Number: 2020394-2016-01280
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741092503
• UDI-Public: (01)00801741092503(17)190831(10)CMAW0006
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: U3575515
• Device Lot Number: CMAW0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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