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

Model Number	VA8074
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The facility rep stated that the device was available for evaluation.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.
Event or Problem Description
It was reported that during an angioplasty procedure the pta balloon allegedly ruptured on the first inflation attempt.It was further reported that the balloon was unable to be removed through the 6fr sheath.When trying to remove the balloon, the outer layer of the balloon allegedly peeled off.A large sheath was placed retrograde central to the antegrade sheath with the balloon, and the ruptured balloon was shared and pulled out through the retrograde sheath.The balloon had to be cut close to the hub in order to pull it out through the second sheath.Upon removing the balloon and sheath from the patient, the patient's access site clotted off and stopped working.The patient was admitted to the hospital to have a thrombectomy the following day.
Event or Problem Description
It was reported that during an angioplasty procedure the pta balloon allegedly ruptured on the first inflation attempt.It was further reported that the balloon was unable to be removed through the 6fr sheath.When trying to remove the balloon, the outer layer of the balloon allegedly peeled off.A large sheath was placed retrograde central to the antegrade sheath with the balloon, and the ruptured balloon was shared and pulled out through the retrograde sheath.The balloon had to be cut close to the hub in order to pull it out through the second sheath.Upon removing the balloon and sheath from the patient, the patient's access site clotted off and stopped working.The patient was admitted to the hospital to have a thrombectomy the following day.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation in three segments.A visual inspection of the third segment consisting of the balloon, polyimide, and snare did not find any peeling of the balloon.Therefore, the investigation is unconfirmed for the reported peeling.In addition, the balloon was unable to be inflated due to the condition of the device.Therefore, the investigation is inconclusive for the reported balloon rupture.The device was also unable to be tested for the reported retraction issue due to the condition of the device and because the sheath used in the procedure was not returned.Therefore, the investigation is inconclusive for the reported retraction issue.However, a visual inspection of the second and third segments found a proximal balloon joint break.Therefore, the investigation is confirmed for the identified proximal balloon joint break.It is possible that the alleged balloon rupture may have contributed to the reported retraction issue.It is also possible that the identified balloon bond break may have contributed to the reported retraction issue.However, the definite root cause for the reported balloon rupture or retraction issue could not be determined based upon the available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: VACCESS 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: 8421995
• Report Number: 2020394-2019-00185
• Device Sequence Number: 16219149
• Product Code: DQY
• UDI-Device Identifier: 00801741121319
• UDI-Public: (01)00801741121319
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: VA8074
• Device Catalogue Number: VA8074
• Device Lot Number: 93YC0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 76