MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 9FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAB-R950-U
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the doctor noted that the intra-aortic balloon (iab) was "cork screwing on itself" and appear to be "spiraling or coiling inside the catheter shaft".The movement cause the catheter placement to "move backwards 4-5 inches".The doctor repositioned the catheter two or three times.As a result, the doctor removed and replaced the catheter with another iab.There was no report of patient complication or serious injury and death.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "iab catheter migrated" is confirmed.The product was not returned for investigation, but visual review of the submitted video shows evidence of abnormal catheter movement during therapy.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported the doctor noted that the intra-aortic balloon (iab) was "cork screwing on itself" and appear to be "spiraling or coiling inside the catheter shaft".The movement cause the catheter placement to "move backwards 4-5 inches".The doctor repositioned the catheter two or three times.As a result, the doctor removed and replaced the catheter with another iab.There was no report of patient complication or serious injury and death.

• Brand Name: REDIGUARD IAB: 9FR 50CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7747044
• Report Number: 3010532612-2018-00236
• Device Sequence Number: 1560581
• Product Code: DSP
• UDI-Device Identifier: 00801902010803
• UDI-Public: 00801902010803
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K010330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

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: 03/31/2019
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: 18F17C0063
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 136