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

Model Number	AT75166
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 03/2024).
Event or Problem Description
It was reported that during post dilation procedure, the pta balloon allegedly failed to deflate.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.The first photo shows the product labeling which verified with the material grid and the second photo looks like the balloon is in partially deflated condition.The balloon appeared bloody.There were no other anomalies noted on the provided photo and no evidence of cut noted on the balloon.Based on the photo review the reported deflation problem remains inconclusive.A definitive root cause for the alleged deflation problem could not be determined based upon the provided 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: (expiry date: 03/2024).H11: section a through f - the information provided by bd 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 bd.H3 other text: device not returned.
Event or Problem Description
It was reported that during post dilation procedure, the pta balloon allegedly failed to deflate.It was further reported that the procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a post dilation angioplasty procedure, the pta balloon allegedly failed to deflate.It was further reported that the a small nick was made to the balloon to deflate.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one atlas pta dilatation catheter has returned for evaluation.On the visual evaluation it was noted a tear/rupture was made on the balloon, which was reported by the user facility to deflate the balloon.No other specific anomalies noted on the returned device.No functional testing performed due to the condition of the returned device.All the anomalies noted on the microscopic observation.Two electronic photos were provided and reviewed.The first photo shows the product labeling which verified with the material grid and the second photo looks like the balloon is in partially inflated condition at the distal end of the balloon and the balloon appeared bloody.No other specific anomalies noted on the submitted photo.Hence based on the photo review and returned sample evaluation, the reported deflation problem remains inconclusive.A definitive root cause for the alleged deflation problem could not be determined based upon the provided 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: (expiry date: 03/2024).H11: section a through f - the information provided by bd 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 bd.H3 other text: see h10.

• 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: 12329702
• Report Number: 2020394-2021-01480
• Device Sequence Number: 4425123
• Product Code: DQY
• UDI-Device Identifier: 00801741062476
• UDI-Public: (01)00801741062476
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• 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): 11/23/2021

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: AT75166
• Device Catalogue Number: AT75166
• Device Lot Number: GFFQ1385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 08/30/2021; 11/26/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/01/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 136 KG