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

Model Number	IPN000261
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient in the cath lab for hemodynamically unstable stemi, preop.Open heart surgery (ohs) was performed on the patient and returned to operating room (or).When the patient was returned to the unit and the iab placement was noted as low on cxr.The dr.Repositioned the iab at bedside and alarms occurred and blood was noted.As a result, the iab was successfully removed at bedside without incident.The patient remained stable post removal, another other iab was inserted, therapy was discontinued.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
Qn #(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.During the investigation, the iabc central lumen was noted broken near the proximal end of the bladder, which caused blood to enter the helium pathway.Additionally, there was more damage found near the location of the central lumen break; however, the cause of the damage could not be determined.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 risk.This will be monitored for any developing trends.Corrected data: correction, no other iab was inserted into the patient.Therapy was discontinued.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) was inserted into the patient in the cath lab for hemodynamically unstable stemi, preop.Open heart surgery (ohs) was performed on the patient and returned to operating room (or).When the patient was returned to the unit and the iab placement was noted as low on cxr.The dr.Repositioned the iab at bedside and alarms occurred and blood was noted.As a result, the iab was successfully removed at bedside without incident.The patient remained stable post removal, another other iab was inserted, therapy was discontinued.There was no report of patient complications, serious injury or 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: 11757305
• Report Number: 3010532612-2021-00126
• Device Sequence Number: 14334403
• Product Code: DSP
• UDI-Device Identifier: 00801902010803
• UDI-Public: 00801902010803
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/13/2021

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: 07/31/2021
• Device Model Number: IPN000261
• Device Catalogue Number: IAB-R950-U
• Device Lot Number: 18F19H0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1