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

Model Number	AT75164
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/22/2021
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.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2023).
Event or Problem Description
It was reported that during a central venoplasty procedure through the promixal right brachiocephalic vein, the device allegedly ruptured transversely and got stucked at the tip of the shealth upon removal.Patient was sent to surgical team to do open surgery for retrieval of balloon and repairing of central veins.Venoplasty procedure was abandoned.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a central venoplasty procedure through the promixal right brachiocephalic vein, the device allegedly ruptured transversely and got stucked at the tip of the shealth upon removal.Patient was sent to surgical team to do open surgery for retrieval of balloon and repairing of central veins.Venoplasty procedure was abandoned.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was conducted and it was determined that a device history record review was not required.Investigation summary: one device was returned for evaluation.The device was noted to be bloody and the distal end of the balloon was noted to be bunched.The returned sheath was retracted and a break was noted at the proximal balloon glue joint.Moreover, the glue joint was noted to be pulled and noted to not be seated correctly.No further functional evaluation was performed due to the condition of the returned device.One electronic images was reviewed.The photo shows the device outside of any packaging.The device is noted to bloody with a sheath still loaded on it and the balloon prolapsed at the distal end.Based on the photo review, no confirmations can be made regarding the reported failure modes.Therefore, the investigation is unconfirmed for the reported balloon rupture, as the failure mode could not be evaluated for.The investigation is confirmed for the identified break, as a break was noted to the proximal balloon glue joint.The definitive root cause for the balloon rupture and break could not be determined based upon available 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: (expiry date: 07/2023).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 : see h10.
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: one device was returned for evaluation loaded into an introducer sheath.The device was noted to be bloody and the distal end of the balloon was noted to be bunched.The returned sheath was retracted and a break was noted at the proximal balloon glue joint.Moreover, the glue joint was noted to be pulled and noted to not be seated correctly.No further functional evaluation was performed due to the condition of the returned device.One electronic images was reviewed.The photo shows the device outside of any packaging.The device is noted to bloody with a sheath still loaded on it and the balloon prolapsed at the distal end.Based on the photo review, no confirmations can be made regarding the reported failure modes.Therefore, the investigation is inconclusive for the reported balloon rupture, as the failure mode could not be evaluated due to the condition of the received device.The investigation is confirmed for the reported difficulty to remove, as the device was returned in the introducer sheath.The investigation is confirmed for the identified break, as a break was noted to the proximal balloon glue joint.The definitive root cause for the reported balloon rupture, and identified removal issue and balloon joint break could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 07/2023).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 during a central venoplasty procedure through the proximal right brachiocephalic vein, the pta balloon allegedly ruptured transversely at 6 atm.It was further reported that the balloon allegedly got stuck at the tip of the sheath during removal.Patient was sent to surgical team to do open surgery for retrieval of the balloon and repairing of central veins.Venoplasty procedure was abandoned.The current status of the patient is unknown.

• Brand Name: ATLAS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11676550
• Report Number: 2020394-2021-00860
• Device Sequence Number: 3538173
• Product Code: DQY
• UDI-Device Identifier: 00801741062469
• UDI-Public: (01)00801741062469
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2022

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 Model Number: AT75164
• Device Catalogue Number: AT75164
• Device Lot Number: GFEU2365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 02/17/2022
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/13/2021; 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 70 KG