MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number U41502H22

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being 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 Description

It was reported that the device allegedly did not look right after opening the inner packaging.There was no patient contact.

Manufacturer Narrative

Manufacturing review: 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.This is the only complaint reported to date for this lot number and failure mode.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 2.5mm x 220mm x 150cm balloon.The device was examined under microscopic magnification and a complete circumferential break was noted on the inner lumen 33.2cm from the distal tip, and a completed circumferential break of the outer catheter was noted at the glue joint.The inner lumen measured 119.8cm from the strain relief to the circumferential break in the lumen; stretching was noted to the inner lumen at the point of the break.The balloon segment of the device included the distal tip, the balloon and a portion of the inner lumen.No other anomalies were noted to the bifurcate or proximal portion of the catheter.Functional/performance evaluation: functional testing was not conducted to the returned 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 device was returned in two complete segments.The device was examined under microscopic magnification and breaks were noted to the inner lumen and outer catheter, with the entire balloon detached from the proximal end of the device.Therefore, the investigation is confirmed for a break and for balloon detachment.Additionally, the investigation is inconclusive for the device not looking right when removed from the packaging, as the device was returned already opened from the packaging, and as the original condition of the device could not be verified.Stretching was noted at the inner lumen break, likely indicating that force was applied to the returned device.It is likely that the force applied to the device resulted in the breaks in the device and the detached balloon.However, the definitive root cause for the reported issue could not be determined based upon the available information.It is unknown if procedural issues during removal of the device from the packaging contributed to the reported event.Labeling review: the current ifu (instructions for use) states: dilatation catheter preparation: remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.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 equipment required.Luer lock syringe/inflation device with manometer (10 ml or larger).

Event Description

It was reported that the device allegedly did not look right after opening the inner packaging.There was no patient contact.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 6592962
• MDR Text Key: 76033745
• Report Number: 2020394-2017-00526
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658(17)191031(10)CMAY0514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: U41502H22
• Device Lot Number: CMAY0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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