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 Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon (iab) was prepped and inserted via a sheath.After insertion the md could not aspirate the central lumen and as a result , the iab was removed.The md used the same insertion site and inserted another iab successfully.There was no reported patient death, complications, or injury.Surgical / medical intervention was not required.There was no reported delay or interruption in iabp therapy.The patient outcome is fine.

Manufacturer Narrative

(b)(4).Device evaluation: returned for evaluation was an 8.0fr 40cc iab fos (fiberoptix sensor) assembly.Dried blood was noted on the bifurcate and catheter.The bladder membrane was fully wrapped upon return.The transducer kit was also returned for evaluation.No kinks were noted on the central lumen.The fos connector and cal key were examined.The gray fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.The blue clamshell housing was examined and no damage was noted.The cal key was intact.The yellow cabling was slightly pulled away at the base of the blue clamshell housing.The fiber was still intact.No issues were noted with the fos in the event details and the issue found is unrelated to the reported complaint.A lab inventory spring wire guide (swg) was inserted through the luer end of the catheter.No resistance was noted and the s wg was able to advance.The swg was inserted through the distal tip.No resistance was noted and the swg was able to advance.No blood or debris exited with the swg.The central lumen was able to be aspirated and flushed.The iab was submerged in water and leak tested.The iab passed leak test.No holes or leaks were found on the bladder membrane.See other remarks section for continuation.Other remarks: 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 cal key and fos were connected to the intra-aortic balloon pump (iabp).The cal key and the fos were recognized.The fos displayed an "eo" (excessive offset) status.After manually zeroing the fos, the status on the pump was still eo.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of unable to aspirate or flush the central lumen is not able to be confirmed.The central lumen was able to aspirated and flushed.The guidewire was able to freely move through the central lumen with no resistance.The root cause of the complaint is undetermined.

Event Description

It was reported that the intra-aortic balloon (iab) was prepped and inserted via a sheath.After insertion the md could not aspirate the central lumen and as a result , the iab was removed.The md used the same insertion site and inserted another iab successfully.There was no reported patient death, complications, or injury.Surgical / medical intervention was not required.There was no reported delay or interruption in iabp therapy.The patient outcome is fine.

• 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: 5194791
• MDR Text Key: 30055127
• Report Number: 1219856-2015-00223
• 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: Initial,Followup
• Report Date: 10/12/2015

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: 08/31/2016
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F14H0030
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2014
• 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 Age: 59 YR
• Patient Weight: 121