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

Model Number	U41502H25RX
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 10/2022).
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly failed to inflate.It was further reported that the balloon successfully inflated outside the patient's body, but it failed to deflate.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly failed to inflate.It was further reported that the balloon successfully inflated outside the patient's body, but allegedly failed to deflate.Reportedly, another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse rx pta dilatation catheter has returned for evaluation.On the visual evaluation of the device, it appeared to have saline residues and a kink was noted below the proximal end of the maker band.The balloon noted to be partially inflated and the inflation lumen noted to be fully inflated.Microscopic observation confirms the kink and the partially inflated balloon and fully inflated inflation lumen.On the functional evaluation of the device, the guide wire lumen was flushed, and an in-house guidewire was able to insert throughout the catheter without any issue.On further the balloon inflated using the in-house presto inflation device, however the balloon did not inflate, the more pressure was applied the to inflate the balloon, and it started to inflate slowly.Once the balloon maintained the pressure, multiple attempts made to deflate the balloon, but it was unsuccessful.Therefore, the investigation was confirmed for the reported inflation issue as the balloon required more pressure to inflate when tried to inflate with the inflation device.The investigation has also confirmed the reported deflation issue as once the balloon maintains the pressure, multiple attempts were made to deflate but it was unsuccessful.The investigation also confirms for the identified material deformation as the kink noted on the balloon inflation lumen proximally noted from the marker band on the device returned for evaluation.A definitive root cause for the alleged inflation, deflation issue, identified material deformation could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 10/2022), g3 h11: h6 (result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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 bd.See h10.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11419502
• Report Number: 2020394-2021-00444
• Device Sequence Number: 11723451
• Product Code: LIT
• UDI-Device Identifier: 00801741056680
• UDI-Public: (01)00801741056680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2021

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 Model Number: U41502H25RX
• Device Catalogue Number: U41502H25RX
• Device Lot Number: CMDY0438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other