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

Catalog Number IAB-05830-LWS

Device Problem Fluid/Blood Leak (1250)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the while in the cath lab the iab was prepped and inserted via a sheath into the patients left femoral successfully.The patient received iabp therapy for nine days.The iabp therapy was completed successfully and upon removal the md found that the iab could not be removed due to entrapment.As a result , the iab was removed by "forcing the extraction" no surgical intervention required.The patient outcome is described as in "recovery." there was no reported patient death, injury or complications.Pump strips were not generated.X-rays were performed but are not available for review.

Manufacturer Narrative

(b)(4).Returned for evaluation was a damaged 30cc 8.0fr fos iab in a brown shipping box.Blood was noted on the bifurcate and other areas of the device.Dried blood was noted within the bladder membrane.The guidewire was returned inserted within the catheter.The distal end of the teflon sheath was located approximately 45.0cm from the distal tip of the catheter.The bladder was fully unwrapped.A 7.0cm radius bend was noted on the central lumen throughout the bladder membrane.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 of the fos was centered.The blue clamshell housing was examined and no abnormalities were noted.The cal key was intact.The bladder thickness was measured at six points with measurements within specification.The bladder thickness was measured directly at the location of the abrasion found during functional testing approximately 21.0cm from the distal tip of the catheter.The thickness was out of specification.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 iabp.The cal key was recognized, but the fos was not recognized.The fos status was "ll pl" indicating a potentially broken fiber.The fiber was found broken approximately 21.0cm from the distal tip of the catheter.The device was submerged under water and leak tested.The device failed leak test.Three leaks were noted on the device.The first leak was noted at the distal tip of the device indicating a broken central lumen.Two other leaks were noted approximately 10.0cm and 21.0cm from the distal tip of the catheter.Under microscopic inspection, abrasions consistent with contact from calcified plaque were noted at the leak sites on the bladder membrane.The distal tip was also found separated from the central lumen which was found unraveling.The guidewire was not able to be withdrawn from the device.The damage to the central lumen is consistent with removal difficulty.A device history record (dhr) 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 removal difficulty is confirmed.The central lumen was found broken off from the distal tip, and the guidewire could not be removed from the device.The damage is consistent with removal difficulty.Dried blood was found in the bladder membrane, and leak sites were found on the bladder membrane as a result of abrasions from contact with calcified plaque.The blood found within the bladder membrane could have potentially led to removal difficulties through entrapment.The root cause of the removal difficulty is undetermined.

Event Description

It was reported that the while in the cath lab the iab was prepped and inserted via a sheath into the patients left femoral successfully.The patient received iabp therapy for nine days.The iabp therapy was completed successfully and upon removal the md found that the iab could not be removed due to entrapment.As a result , the iab was removed by "forcing the extraction" no surgical intervention required.The patient outcome is described as in "recovery." there was no reported patient death, injury or complications.Pump strips were not generated.X-rays were performed but are not available for review.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• 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: 6034476
• MDR Text Key: 57682977
• Report Number: 1219856-2016-00236
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/22/2016

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-05830-LWS
• Device Lot Number: 18S16E0005
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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