MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOOON

Catalog Number IAB-05830-U

Device Problem Material Separation (1562)

Patient Problems Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 04/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-balloon catheter (iab) was inserted while the patient was in the cath.Lab.One of the cath lab personnel asked another staff member if this iab-05830-u was on the recall list, and she was told it was not on the list.The next day, 16 hours later, the staff was called in to put in a temporary pacemaker at the patient's bedside.They noticed "oozing" around the insertion site of the iab.They covered the site and 30 minutes later noticed it was saturated in blood.The sheath separated from the hub and the md removed the iab.The md did not replace the iab.According to the md the patient later expired due to other medical complications unrelated to the iab.On 04/15/2016 additional information: was received from patient safety staff.The iab insertion site was noted oozing when palpitating for a temporary pacemaker insertion the following day.The decision to remove the iab and not replace it was made by the md and the family.The patient was not doing well despite being on multiple drips for bp control.The family requested no more intervention.The patient expired and the cause of death was listed as myocardial infarction.

Manufacturer Narrative

(b)(4).Device evaluation: returned for evaluation was a 30cc 8fr iab.The 30cc driveline tubing typically supplied with the iab kit was also returned for evaluation the teflon sheath was on the iab upon return.The distal end of the sheath was located approximately 34.0cm from the distal tip of the catheter.Blood was noted on the exterior of the sheath body and sheath hub upon return.The proximal end of the teflon sheath was returned detached from the teflon sheath hub.Engineering has been notified of the event.The bladder thickness was measured at various locations and was within specification.The iab was submerged in water and leak tested.The iab passed leak test.No holes or leaks were found on the bladder membrane.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.This device was found to be a part of the recall for the sheath separation issue.Conclusion: the reported complaint of sheath separation is confirmed.The root cause of the separation is process related.Nonconformance (b)(4) was previously initiated to investigate the issue.Capa (b)(4) has also been initiated to investigate the issue.Other remarks: the lot number associated with this complaint was a part of a field corrective action enacted on february 9, 2016.The event took place after the recall date.

Event Description

It was reported that the intra-balloon catheter (iab) was inserted while the patient was in the cath lab.One of the cath lab personnel asked another staff member if this iab-05830-u was on the recall list, and she was told it was not on the list.The next day, 16 hours later, the staff was called in to put in a temporary pacemaker at the patient's bedside.They noticed "oozing" around the insertion site of the iab.They covered the site and 30 minutes later noticed it was saturated in blood.The sheath separated from the hub and the md removed the iab.The md did not replace the iab.According to the md the patient later expired due to other medical complications unrelated to the iab.On (b)(6) 2016 additional information: was received from patient safety staff.The iab insertion site was noted oozing when palpitating for a temporary pacemaker insertion the following day.The decision to remove the iab and not replace it was made by the md and the family.The patient was not doing well despite being on multiple drips for bp control.The family requested no more intervention.The patient expired and the cause of death was listed as myocardial infarction.

• Brand Name: ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- AORTIC BALLOOON
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5608885
• MDR Text Key: 43665032
• Report Number: 1219856-2016-00095
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Risk Manager
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: IAB-05830-U
• Device Lot Number: 18F14H0019
• Other Device ID Number: 00801902010742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 74