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

Catalog Number U3575104

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 during an angioplasty procedure, the pta balloon was allegedly difficult to insert through the introducer sheath.It was further reported that an alleged kink was identified.The pta balloon was exchanged for another and the procedure was completed.There was no patient contact.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The device history records were reviewed with special attention to the receiving inspection data, internal rejects history, and manufacturing controls.The lot met all test released criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Visual/microscopic inspection: the sample was returned.The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 10mm x 40mm balloon.A complete circumferential catheter detachment was identified to the catheter.No other anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: the strain relief was removed from the y-hub.A complete circumferential catheter detachment was identified near the bifurcate, 2.0cm from the bifurcate.The catheter detachment was examined under microscopic magnification (10x) and the edges of the break were jagged.Sanding marks were noted on the catheter at the location of the break.Further functional testing could not be performed due to sample condition.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 investigation was confirmed for a complete circumferential catheter detachment just distal to the y-hub.The investigation was inconclusive for difficult to insert, as functional testing could not be performed due to the poor sample condition.Additionally, the investigation was unconfirmed for kinked catheter, as no kinks were identified.Excessive sanding of the catheter under the strain relief was the root cause for the catheter detachment.It is possible the detachment contributed to the insertion issues.Corrective and preventative actions have been implemented, this lot is pre corrective action.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 or catheter breakage, catheter kink, or balloon separation.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter 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 introducer sheath/guide catheter as a single unit.Potential adverse reactions the complications that may result from a peripheral balloon dilatation procedure include: additional intervention.Use of ultraverse 035 pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.While maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the introducer sheath/guide catheter and withdraw the deflated dilatation catheter over the wire through the introducer sheath/guide catheter.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath/guide catheter.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, the pta balloon was allegedly difficult to insert through the introducer sheath.It was further reported that an alleged kink was identified.The pta balloon was exchanged for another and the procedure was completed.There was no patient contact.

• 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: 6378664
• MDR Text Key: 69165884
• Report Number: 2020394-2017-00144
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094583
• UDI-Public: (01)00801741094583(17)160731(10)50113329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: U3575104
• Device Lot Number: 50113329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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