MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CARDIAC UNKNOWN MATERIAL; INTRA- AORTIC BALLOOON PRODUCTS

Catalog Number CARDIAC UNKNOWN

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528)

Patient Problems Death (1802); Thrombus (2101)

Event Date 09/19/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had an intra-aortic balloon (iab) inserted and was receiving iabp therapy.The pump s/n (b)(4) alarmed three times, and the iab was removed 30 minutes or later.The nurse practitioner removed the iab and noted that there were clots formed on several areas of the balloon.The patient was not on heparin.The patient has expired.Additional information received on 10/5/2016: the balloon ruptured and the alarmed sounded several times.The attending instructed the np (nurse practitioner) not to extract the balloon at first but then instructed the np, to remove the catheter.Upon removal, the catheter developed several clots making it difficult to remove.Finally the catheter was removed but the clot migrated down the patient's leg.As a result of the clot moving, an embolectomy had to be performed.The responds to the alarms may have been longer than the 30 min window for clot development.

Manufacturer Narrative

(b)(4) additional information received on 11-29-2016 from the field service report that blood entered the intra-aortic balloon pump.The product was not returned for evaluation.The specific lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers shipped to this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.The product was not returned for evaluation.The root cause of the complaint is undetermined.

Event Description

It was reported that the patient had an intra-aortic balloon (iab) inserted and was receiving iabp therapy.The pump s/n (b)(4) alarmed three times, and the iab was removed 30 minutes or later.The nurse practitioner removed the iab and noted that there were clots formed on several areas of the balloon.The patient was not on heparin.The patient has expired.Additional information received on 10/5/2016: the balloon ruptured and the alarmed sounded several times.The attending instructed the np (nurse practitioner) not to extract the balloon at first but then instructed the np, to remove the catheter.Upon removal, the catheter developed several clots making it difficult to remove.Finally the catheter was removed but the clot migrated down the patient's leg.As a result of the clot moving, an embolectomy had to be performed.The responds to the alarms may have been longer than the 30 min window for clot development.

• Brand Name: CARDIAC UNKNOWN MATERIAL
• 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: 6072837
• MDR Text Key: 58971694
• Report Number: 1219856-2016-00234
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CARDIAC UNKNOWN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• 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
• Patient Outcome(s): Death; Required Intervention