MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION BALLOON; BALLOON VALVULOPLASTY CATHETER

Catalog Number	0244512
Medical Device Problem Codes	Leak/Splash (1354); Aspiration Issue (2883)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional 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 was 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 or Problem Description
It was reported that the balloon catheter allegedly leaked during deflation.There was no patient contact.
Additional 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 event reported to date for this lot number and failure mode.Visual inspection: the sample appears to be clean.The balloon size for this product was printed on the balloon hub of the catheter and identified the return sample as a 24mm x 4.5cm.No holes or catheter damage was identified.No anomalies were noted to the device.Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0.035" guidewire and it passed without issue.The balloon was inflated to nominal pressure and rated burst pressure without issues.The balloon was deflated without issue; however, air could be heard aspirating from the device.Removed balloon from the distal end of the device to examine the polyimide and balloon joints.No damage was noted to the inner polyimide or balloon joints.Marker bands were present and intact in the correct location.The outer catheter was peeled back to the strain relief to examine the rest of the inner polyimide.No damage was noted throughout entire length of polyimide.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was returned.Although the sample was able to fully inflate and deflate without issue, the investigation was confirmed for the reported aspiration issues, as air could be heard aspirating during deflation of the device.The definitive root cause could not be determined based upon the available information.Labeling review: the current instructions for use (ifu) states: warnings & precautions: never use force when advancing or retracting intravascular device without first angiographically determining cause for any resistance.Using force may damage catheter or cause injury to the patient (such as vessel perforation).Do not exceed maximum inflation pressure indicated on label.Excess inflation pressure can cause balloon rupture and the inability to withdraw catheter through introducer sheath.Withdrawing balloon through introducer sheath may damage balloon.Balloon deflation and catheter removal: deflate balloon by drawing vacuum on the = 50 cc inflation device.Use fluoroscopy to visually confirm that balloon has fully deflated prior to withdrawing catheter.While maintaining negative pressure and guidewire position, withdraw deflated device over the guidewire and out through introducer sheath.Use of a gentle clockwise twisting motion may be used to help withdraw balloon through introducer sheath.If unusual resistance is met when attempting to withdraw balloon, position balloon in anatomical position in which it can be inflated safely.Partially inflate balloon and then deflate it.Balloon re-folding can be observed under fluoroscopy.Use of recommended contrast concentration will facilitate fluoroscopic visualization of balloon re-folding.If balloon will not pass through introducer sheath for removal, remove balloon and sheath as a single unit.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 or Problem Description
It was reported that the valvuloplasty balloon allegedly aspirated while pulling negative pressure.There was no reported patient injury.

• Brand Name: TRUE DILATATION BALLOON
• Common Device Name: BALLOON VALVULOPLASTY CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6358768
• Report Number: 2020394-2017-00108
• Device Sequence Number: 10970227
• Product Code: OZT
• UDI-Device Identifier: 00801741091001
• UDI-Public: (01)00801741091001(17)190828(10)GFAV1547
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Catalogue Number: 0244512
• Device Lot Number: GFAV1547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR