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

Model Number	AT75224
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 been received for the evaluation.On the visual evaluation, the device was noted to be bloody and no other anomalies were noted.On the functional evaluation, the guidewire lumen was flushed and the patency of the guidewire lumen was tested using returned boston specific amplatz super stiff and an in-house guidewire.In both instances guidewires were unable to be loaded.On further, the catheter was cut and noted that the part of returned guidewire was stuck and got detached, which was trapped inside the inner guidewire lumen and it was examined under the microscopic observation.No other functional testing was performed.Therefore the investigation for the reported difficult to remove and device-device incompatibility was confirmed as the guidewire was stuck within the inner guidewire lumen and got detached.The investigation for the identified detachment of guidewire was confirmed as the guidewire was stuck and got detached during the withdrawal.A definitive root cause for the reported difficult to remove, device-device incompatibility and the identified detachment of guidewire 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.Expiration date: (expiry date: 05/2024).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck on the guidewire.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 been received for the evaluation.On the visual evaluation, the device was noted to be bloody and no other anomalies were noted.On the functional evaluation, the guidewire lumen was flushed and the patency of the guidewire lumen was tested using returned boston specific amplatz super stiff and an in-house guidewire.In both instances guidewires were unable to be loaded.On further, the catheter was cut and noted that the part of returned guidewire was stuck and got detached, which was trapped inside the inner guidewire lumen and it was examined under the microscopic observation.No other functional testing was performed.Therefore the investigation for the reported difficult to remove and device-device incompatibility was confirmed as the guidewire was stuck within the inner guidewire lumen and got detached.The investigation for the identified detachment of guidewire was confirmed as the guidewire was stuck and got detached during the withdrawal.A definitive root cause for the reported difficult to remove, device-device incompatibility and the identified detachment of guidewire 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: d4 (expiry date: 05/2024), g3.H11: g2.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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly got stuck on the guidewire.There was no reported patient injury.

• 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
• MDR Report Key: 12587816
• Report Number: 2020394-2021-01838
• Device Sequence Number: 4103238
• Product Code: DQY
• UDI-Device Identifier: 00801741062544
• UDI-Public: (01)00801741062544
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: AT75224
• Device Catalogue Number: AT75224
• Device Lot Number: GFFS2153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1