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

Model Number D1604081475

Device Problems Accessory Incompatible (1004); Failure to Fold (1255); Difficult to Open or Close (2921); Mechanical Jam (2983); Failure to Deflate (4060)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During procedure the balloon did not deflate/ refold correctly.There was difficulty in retrieval and guide catheter tip was damaged.No complications occured.

Manufacturer Narrative

Follow up report for additional information not known at the time of original report, such as, investigation type, findings, and conclusion.

Event Description

Follow up report for (b)(6); mfr report #: 3005994106-2021-00003.

• Brand Name: DYNAMICS AV
• Type of Device: 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
• MDR Text Key: 255925193
• Report Number: 3005994106-2021-00003
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 05391525783369
• UDI-Public: 05391525783369
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K143561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: D1604081475
• Device Lot Number: 21802354
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1