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

Model Number U3575104

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

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 return of the device is pending.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 preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported 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.Visual/microscopic inspection: as the sample was not returned for evaluation, a visual/microscopic inspection could not be performed.Functional/performance evaluation: as the sample was not returned for evaluation, a functional/performance evaluation could not be performed.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 is inconclusive, as the sample was not returned for evaluation.The definitive root cause could not be determined based upon the available information.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 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.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.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 preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported 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 device was returned still sealed in the inner sterile packaging; the pouch had not been opened.The inner packaging was returned inside of the outer packaging box.The user had indicated with an arrow on the inner packaging where the alleged foreign material was located.The hoop was examined under microscopic magnification (30x) through the seal packaging, and a dark foreign particle was visible; however, the inner packaging and hoop made it unable to be inspect the particle further without opening the device.Additional evaluation performed by the manufacturing site: visual inspection: the returned pouch was initially visually inspected for hoop contamination/foreign material.A dark particle was identified, possibly inside the 2nd hoop coil.However, at this point it could not be confirmed if this was an embedded plastic imperfection or some form of contamination.The hoop was removed from the pouch and upon closer inspection a particle was identified inside of the hoop.The hoop was then cut and a particle was removed from the inside of the hoop.The particle was measured and found to be outside the acceptable guidelines for particle size.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 for evaluation.The inner packaging was examined under magnification, and one dark particle was visible.The device was then sent to the manufacturing site for further evaluation.The packaging was opened, and a particle was found inside the inner hoop.The particle was measured and found to be outside the acceptable guidelines for particle size per the manufacturing sites standards.The investigation is confirmed for foreign material in the inner packaging.Per the evaluation of the returned device, the foreign particle size is outside the acceptable guidelines.However, the definitive root cause for the particle in the hoop could not be determined based upon the available information.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.In order to activate the hydrophilic coating, it is recommended to wet the ultraverse catheter with sterile saline solution immediately prior to its insertion in the body.Dilatation catheter preparation: remove catheter from package.Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled.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.

Event Description

It was reported that during preparation for an angioplasty procedure the sterile packaging allegedly contained a particle inside.There was no reported 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: 6314084
• MDR Text Key: 67236890
• Report Number: 2020394-2017-00052
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741094583
• UDI-Public: (01)00801741094583(17)190531(10)50140454
• Combination Product (y/n): N
• Reporter Country Code: TN
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Model Number: U3575104
• Device Catalogue Number: U3575104
• Device Lot Number: 50140454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided; 07/17/2017
• Supplement Dates FDA Received: 03/15/2017; 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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