MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; INTRA-AORTIC BALLOON FIBER OPTIC SYS

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 04/09/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Sample will not be returned for evaluation.

Event Description

It was reported that while in the cath lab the md inserted an intra-aortic balloon (iab) via the right femoral artery.A competitor's introducer sheath was used due to the recall.One hour after the patient was transported to the intensive care unit multiple alarms were noted with blood coming into the lumen.The device was removed and not replaced.There was not another attempt to reinsert the catheter.There was a complication listed as a delay/ interruption in therapy.The patient expired.

Manufacturer Narrative

(b)(4) no product was returned for evaluation.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that while in the cath lab the md inserted an intra-aortic balloon (iab) via the right femoral artery.A competitor's introducer sheath was used due to the recall.One hour after the patient was transported to the intensive care unit multiple alarms were noted with blood coming into the lumen.The device was removed and not replaced.There was not another attempt to reinsert the catheter.There was a complication listed as a delay/ interruption in therapy.The patient expired.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA-AORTIC BALLOON FIBER OPTIC SYS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 5659332
• MDR Text Key: 45298847
• Report Number: 1219856-2016-00101
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15L0002
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 113