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

Catalog Number IAB-05840-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was been reported that while in the cath lab the intra-aortic balloon catheter (iab) was prepped per instruction.The iab was inserted and the patient was sent to surgery.At this time the rn stated that the iab ruptured and was removed.A new iab was retrieved and inserted without difficulty.There was no reported death, injury or harm to the patient.There was a "mild delay" in iabp therapy for the time frame required to prep the new iab and they also brought a second pump into the or for use.

Manufacturer Narrative

(b)(4).No product was returned for evaluation.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for all the lot numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.If the sample is returned at a later date, a full investigation will be completed.

Event Description

It was been reported that while in the cath lab the intra-aortic balloon catheter (iab) was prepped per instruction.The iab was inserted and the patient was sent to surgery.At this time the rn stated that the iab ruptured and was removed.A new iab was retrieved and inserted without difficulty.There was no reported death, injury or harm to the patient.There was a "mild delay" in iabp therapy for the time frame required to prep the new iab and they also brought a second pump into the or for use.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: INTRA- AORTIC BALLOON FIBER OPTIC
• 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: 5990257
• MDR Text Key: 56030051
• Report Number: 1219856-2016-00213
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: N/A
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• 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