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

Model Number	DR8094
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured at 14 atm.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly broke at 14 atm.It was further reported that the balloon allegedly had retraction issue.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 dorado pta dilatation catheter has returned for evaluation.On visual evaluation, the device appeared bloody, the balloon has returned with unknow sheath.The sheath appeared to be had bunching at the proximal end and buckled at the distal end.No other specific anomalies noted.On the functional evaluation, the sheath was removed distally exposing the balloon.The inner guide wire lumen of the catheter was flushed, and an in-house guide wire was inserted without any issue, on further the balloon was inflated with in-house presto device.Upon inflating the balloon water was leaked form the balloon glue joint of the catheter and the balloon inflated and maintain pressure and shape.No evidence of balloon rupture observed on the balloon.Microscopic observation was performed to note all the anomalies.Therefore, the investigation was unconfirmed for the reported balloon rupture has unconfirmed as the balloon inflated and no evidence of rupture noted on the device.The investigation has confirmed for the reported retraction issues as the balloon was stuck in the sheath, and the sheath noted bunched and buckled which returned for evaluation.The investigation also confirmed for the identified break as the water leaks form the catheter glue joint due to the break upon inflating the device.A definitive root cause for the alleged balloon rupture, retraction issue and identified break 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: 05/2023), g3.H11: b5, e1, h6 (method, result and conclusion).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.

• Brand Name: DORADO 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: 11587285
• Report Number: 2020394-2021-00739
• Device Sequence Number: 20025264
• Product Code: LIT
• UDI-Device Identifier: 00801741059445
• UDI-Public: (01)00801741059445
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2021

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: DR8094
• Device Catalogue Number: DR8094
• Device Lot Number: 93RE0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/06/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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
• Patient Age: 86 YR
• Patient Weight: 59