MAUDE Adverse Event Report: CREAGH MEDICAL LTD. DYNAMICS AV; PTA CATHERER

Model Number	D1604081475
Medical Device Problem Codes	Accessory Incompatible (1004); Failure to Fold (1255); Difficult to Open or Close (2921); Mechanical Jam (2983); Failure to Deflate (4060)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure the balloon did not deflate/ refold correctly.There was difficulty in retrieval and guide catheter tip was damaged.No complications occured.
Additional Manufacturer Narrative
Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.
Event or Problem Description
Follow up report for (b)(6); mfr report #: 3005994106-2021-00003.

• Brand Name: DYNAMICS AV
• Common Device Name: PTA CATHERER
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; balinasloe, co. galway, galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: mike dunning ; ida business park; balinasloe, co. galway, galway H53 K-8P4 ; EI H53 K8P4
• MDR Report Key: 11890670
• Report Number: 3005994106-2021-00003
• Device Sequence Number: 3202345
• Product Code: LIT
• UDI-Device Identifier: 05391525783369
• UDI-Public: 05391525783369
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K143561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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 Expiration Date: 09/08/2021
• Device Model Number: D1604081475
• Device Lot Number: 21802354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown