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

Model Number	DR4084
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026) 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.H3 other text : device pending return.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the re-sheather was allegedly fused to the balloon and pulled the balloon off the shaft.It was further reported that the when the cover was tried to remove, it allegedly got stuck on the balloon and the catheter allegedly snapped.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the distal part of the catheter.The balloon appears clean.The bond joint area of the balloon is seen circled and the words underneath say 'broke here'.A break at the circled area can be seen, with the balloon noted separated from the outer catheter but still attached to the inner guidewire lumen.No other anomalies noted.Therefore, the investigation is inconclusive for the reported difficult to remove packaging material as no evidence of the failure could be determined from the provided picture.However, the investigation is confirmed for the reported break as the balloon was noted broken at the bond joint.A definitive root cause for the reported difficult to remove packaging material and break could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (expiry date: 03/2026).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.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the balloon protector allegedly did not slide off the balloon and was fused to the balloon.It was further reported when tried to remove the cover the catheter allegedly snapped.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to an angioplasty procedure, the balloon protector allegedly did not slide off the balloon and was fused to the balloon.It was further reported when tried to remove the cover the catheter allegedly snapped.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.One photo was provided and reviewed.The photo shows the distal part of the catheter.The balloon appears clean.The bond joint area of the balloon is seen circled and the words underneath say 'broke here'.A break at the circled area can be seen, with the balloon noted separated from the outer catheter but still attached to the inner guidewire lumen.No other anomalies noted.Therefore, the investigation is inconclusive for the reported difficult to remove packaging material as no evidence of the failure could be determined.However, the investigation is confirmed for the reported break as the balloon was noted broken at the bond joint.A definitive root cause for the reported difficult to remove packaging material and break could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 03/2026), g3, h6 (method).H11: section a through f ¿ the information provided 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.

• Brand Name: DORADO
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17331094
• Report Number: 2020394-2023-00521
• Device Sequence Number: 20494926
• Product Code: LIT
• UDI-Device Identifier: 00801741059247
• UDI-Public: (01)00801741059247
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072283
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: DR4084
• Device Catalogue Number: DR4084
• Device Lot Number: 93QH0157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 11/07/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/28/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown