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 Problems Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Reference mdr #1219856-2015-00196 for the first event involving the same patient.It was reported that while in the cath lab the md began the insertion of the intra-aortic balloon (iab).While threading the iab over the spring wire guide (swg) and into the patient's femoral artery resistance was met.The iab could not be inserted into the patient.The md removed the iab and swg as one unit.Another iab was opened, prepped and successfully inserted in the same insertion site.There was a delay in intra-aortic balloon pump (iabp) therapy for the timeframe required to prep the 4th iab and insert it into the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is listed as the patient is still alive and well.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: returned for evaluation was a 40cc 8.0fr iab fos (fiberoptix sensor) assembly.The stylet was returned inserted within the catheter.The one-way valve was connected to the inflation lumen.The bladder membrane was fully wrapped.Small amounts of dried blood were noted near the tip of the bladder membrane.No blood was noted within the catheter.No damage, abnormalities, or kinks were noted to the catheter.No damage was noted to the stylet.The fos connector and cal key were examined.The gray fos connecter was properly seated in the housing and both retaining tabs were intact.The center post was centered.The cal key was intact.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.The fos and cal key were connected to the intra-aortic balloon pump (iabp) and recognized.The fos zeroed and displayed an "ok" status.The iab was submerged in water and leak tested.No holes or leaks were detected.Full inflation was achieved.The unit passed leak test.A lab inventory spring wire guide (swg) was inserted into the luer end of the iab.No resistance was encountered; the swg was able to advance.See other remarks section for device evaluation continuation.Other remarks: the swg was inserted through the distal tip of the iab.No resistance was encountered the swg was able to advance.No blood or debris exited with the swg.A device history record review was not performed.There was no confirmed product failure with the returned sample.Conclusion: the reported complaint of insertion difficulty is not confirmed.The catheter passed functional testing.The root cause of the complaint is undetermined.

Event Description

Reference mdr #1219856-2015-00196 for the first event involving the same patient.It was reported that while in the cath lab the md began the insertion of the intra-aortic balloon (iab).While threading the iab over the spring wire guide (swg) and into the patient's femoral artery resistance was met.The iab could not be inserted into the patient.The md removed the iab and swg as one unit.Another iab was opened, prepped and successfully inserted in the same insertion site.There was a delay in intra-aortic balloon pump (iabp) therapy for the timeframe required to prep the 4th iab and insert it into the patient.There was no reported patient death, injury or complications.Medical / surgical intervention was not required.The patient outcome is listed as the patient is still alive and well.

• 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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5129689
• MDR Text Key: 27536742
• Report Number: 1219856-2015-00195
• 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: Health Professional
• Type of Report: Followup
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15E0037
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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 Weight: 67