MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 8FR 40CC; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number IAB-S840C

Device Problem Human-Device Interface Problem (2949)

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817)

Event Date 03/23/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) the sample will not be returning for investigation.

Event Description

It was reported that the patient (b)(6).In height, weight estimated related to bedridden received an iab catheter due to angina pectoris on (b)(6) 2016 via the left femoral artery.The iab catheter was removed on (b)(6) 2016.Three days later, the patient appeared with angina pectoris again and ecg (electrocardiogram) changes showing ischemia of the anterior wall.An iab catheter was inserted through the left femoral artery and was sutured to prevent it from migrating inside the patient.The patient complained of severe pain on the left low extremity on (b)(6) 2016.The doctor found the following signs: low temperature of left low extremity, no pulse of left dorsal artery.The thrombosis was diagnosed.Heparin was given, but the ck (creatine kinase), mro and serum cr (creatinine blood test) increased continuously.The left extremity necrosis was diagnosed on (b)(6) 2016 and the iab catheter was removed on the same day.The patient expired due to mof (multi-system organ failure) the next day.The catheter appeared to function appropriately with no issues prior to the noted lower extremity circulation compromise.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.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.Conclusion: there was no reported device failure.No product was returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the patient (b)(6).In height, weight estimated related to bedridden received an iab catheter due to angina pectoris on (b)(6) 2016 via the left femoral artery.The iab catheter was removed on (b)(6) 2016.Three days later, the patient appeared with angina pectoris again and ecg (electrocardiogram) changes showing ischemia of the anterior wall.An iab catheter was inserted through the left femoral artery and was sutured to prevent it from migrating inside the patient.The patient complained of severe pain on the left low extremity on (b)(6) 2016.The doctor found the following signs: low temperature of left low extremity, no pulse of left dorsal artery.The thrombosis was diagnosed.Heparin was given, but the ck (creatine kinase), mro and serum cr (creatinine blood test) increased continuously.The left extremity necrosis was diagnosed on (b)(6) 2016 and the iab catheter was removed on the same day.The patient expired due to mof (multi-system organ failure) the next day.The catheter appeared to function appropriately with no issues prior to the noted lower extremity circulation compromise.

• Brand Name: REDIGUARD IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOOON PRODUCTS
• 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: 5706896
• MDR Text Key: 46822220
• Report Number: 1219856-2016-00123
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K981660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: IAB-S840C
• Device Lot Number: 18F14E0041
• Other Device ID Number: 00801902002679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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: 65 YR
• Patient Weight: 50