MAUDE Adverse Event Report: BD PERIPHERAL INTERVENTION VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	VA5084
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during angioplasty of a venous outflow, the pta balloon allegedly had difficulty being retracted through the 6fr sheath.It was further reported that upon retraction through the sheath, it was identified that a segment of the balloon detached and remained in the patient.The health care provider (hcp) performed a cutdown to remove the detached balloon segment.Guided fluoroscopy demonstrated that the tip of the balloon was missing and was located in the patients arm and then migrated to the pulmonary artery.Reportedly, the hcp decided to conclude treatment and schedule a retrieval procedure following the date of event.The patient was reported as asymptomatic post procedure.
Additional Manufacturer Narrative
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 device was returned for evaluation.A visual inspection was performed and bunching and buckling were noted throughout the sheath.The balloon was not returned with the device.Balloon material was noted at the glue joint.The inner lumen was stretched, with the glue fillet pulled away from the outer shaft.The inner lumen was broken distally from the glue joint.Therefore, the investigation is confirmed for the reported retraction issue, as there was bunching and buckling were noted throughout the sheath.The investigation is confirmed for the balloon detachment, as the balloon was detached from the device and not returned.The investigation is confirmed for the identified catheter shaft detachment, as the inner lumen was broken and detached from the device.The balloon and catheter shaft detachment may have been a result of the retraction issue.However, the definitive root cause for the reported retraction issue, catheter shaft detachment, and balloon detachment could not be determined based upon 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.
Event or Problem Description
It was reported that during angioplasty of a venous outflow, the pta balloon allegedly had difficulty being retracted through the 6fr sheath.It was further reported that upon retraction through the sheath, it was identified that a segment of the balloon detached and remained in the patient.The health care provider (hcp) performed a cutdown to remove the detached balloon segment.Guided fluoroscopy demonstrated that the tip of the balloon was missing and was located in the patients arm and then migrated to the pulmonary artery.Reportedly, the hcp decided to conclude treatment and schedule a retrieval procedure following the date of event.The patient was reported as asymptomatic post procedure.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BD PERIPHERAL INTERVENTION; 1415 w. 3rd street; tempe AZ 85281
• MDR Report Key: 8464617
• Report Number: 2020394-2019-00209
• Device Sequence Number: 345229
• Product Code: DQY
• UDI-Device Identifier: 00801741059728
• UDI-Public: (01)00801741059728
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 10/10/2019

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: 01/07/2022
• Device Model Number: VA5084
• Device Catalogue Number: VA5084
• Device Lot Number: 93ZC0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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: Required Intervention
• Patient Age: 63 YR