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

Catalog Number	DR8078
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.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.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 during a fistulogram the pta balloon allegedly would not come out of the 6fr sheath after completing nine inflations.Reportedly, the balloon began to accordion as it was being withdrawn through the sheath.The sheath and balloon were removed as a single unit.The health care provider used a new sheath and injected contrast in the vessel and confirmed that no further treatment was needed.The patient was reported to be asymptomatic at the conclusion of the procedure.There was no reported patient injury.
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.Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 7mm x 8cm balloon.The first segment consisted of the proximal end of the device to a complete circumferential break at the butt joint.The inner guidewire lumen extended distally from the butt joint break, to a complete circumferential break 1.4cm distal to the butt joint.The edges of the butt joint break were examined under microscopic magnification (16x) and observed to be slightly jagged.The inflation lumens extended out from the butt joint 2.5cm and 0.7cm, respectively.No other anomalies were noted to the first segment.The second segment consisted of the portion of the catheter from the break at the butt joint to the distal tip.This segment was returned stuck within the returned 6fr introducer sheath.This segment was inspected under microscopic magnification (10x) and the balloon was noted to be prolapsed over the distal tip.The sheath was also flared, likely indicating retraction issues.Functional/performance evaluation: no further functional testing could be performed due to the break at the proximal balloon glue joint.The balloon was unable to be removed from the sheath.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.A visual inspection found the balloon was returned in two segments.The segments had broken circumferentially at the butt joint, therefore the investigation is confirmed for a break.Additionally, the distal segment was stuck in an introducer sheath, the distal end of the sheath was found to be flared, and the balloon was prolapsed over the distal tip, confirming the investigation for sheath related retraction issues.It is likely that the retraction issues led to the catheter break at the butt joint.However, the definitive root cause for the retraction issues could not be determined based upon the available information.Labeling review: the current ifu (instructions for use) states: warnings: if resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the sheath 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 guidewire/introducer 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 during a fistulagram the pta balloon allegedly would not come out of the 6fr sheath after completing nine inflations.Reportedly, the balloon began to accordion as it was being withdrawn through the sheath.The sheath and balloon were removed as a single unit.The health care provider used a new sheath and injected contrast in the vessel and confirmed that no further treatment was needed.The patient was reported to be asymptomatic at the conclusion of the procedure.There was no reported patient injury.

• Brand Name: DORADO PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6652513
• Report Number: 2020394-2017-00662
• Device Sequence Number: 13740663
• Product Code: DQY
• UDI-Device Identifier: 00801741059063
• UDI-Public: (01)00801741059063(17)200308(10)93QB0063
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2017

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: 03/08/2020
• Device Catalogue Number: DR8078
• Device Lot Number: 93QB0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 39