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

Catalog Number IAB-05840-LWS

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907); Device Sensing Problem (2917)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call from biomed to the clinical support specialist (css) that biomed was calling to discuss several fiber optic failures.He stated that he had to replace the sensors in several intra-aortic balloon pumps and was being asked to do that again in this situation, but he is not confident that it is the pump.The biomed told the css that he doesn't have the tester and has requested to get one as this seems to be an ongoing problem.The biomed has no patient information.The first intra-aortic balloon (iab) was not used for the patient because the fos was not recognized.He told the css that they have new people in the cath lab that may require in-serving.Additional information: on (b)(6) 2015 the risk manager spoke to the teleflex raqa director and stated that the catheter was inserted and used via transducer; the fos sensor never would zero.Upon removal of the iab the radiopaque tip broke off within the balloon itself.Removal was not forceful.On (b)(6) 2015 it was reported per the clinical coordinator that the patient had to go to surgery for removal of the catheter and is doing well.

Manufacturer Narrative

(b)(4).Additional information: device evaluation: returned for evaluation was an 8.0fr 40cc fos iab.Blood was noted within the bladder membrane.The one-way valve was tethered to the short driveline tubing.The distal end of the teflon sheath was returned approximately 23.5cm from the distal tip of the catheter.The distal tip of the bladder was withdrawn within the bladder membrane.The distal tip was surrounded by dried blood.After clearing the dried blood, the bladder membrane was found punctured by the distal tip.Glue lines were noted at the tip of the bladder membrane.The glue lines show that the catheter was assembled correctly during manufacturing.It is unclear how the distal tip punctured the bladder membrane.Engineering has been notified of the event.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 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.See other remarks section for device evaluation continuation.Other remarks: the cal key and fos were connected to the iabp.The cal key was recognized.The pump status was "ll pl" indicating a potential broken fiber.The broken fiber was noted approximately 1.2cm from the distal tip of the catheter.The full length of the fiber was confirmed present with no other notable breaks.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 that the fos would not zero is confirmed.The fiber was found broken at the distal tip.The reported complaint that the distal tip was broken off from the balloon is not confirmed; however, the bladder was punctured by the distal tip.Glue lines were apparent at the tip of the bladder, which shows that the catheter was assembled correctly.Engineering has been notified of the event.The root cause of the puncturing is undetermined.

Event Description

It was reported via a hot line call from biomed to the clinical support specialist (css) that biomed was calling to discuss several fiber optic failures.He stated that he had to replace the sensors in several intra-aortic balloon pumps and was being asked to do that again in this situation, but he is not confident that it is the pump.The biomed told the css that he doesn't have the tester and has requested to get one as this seems to be an ongoing problem.The biomed has no patient information.The first intra-aortic balloon (iab) was not used for the patient because the fos was not recognized.He told the css that they have new people in the cath lab that may require in-serving.Additional information: on (b)(46 2015, the risk manager spoke to teleflex and stated that the catheter was inserted and used via transducer; the fos sensor never would zero.Upon removal of the iab the radiopaque tip broke off within the balloon itself.Removal was not forceful.On (b)(6) 2015, it was reported per the clinical coordinator that the patient had to go to surgery for removal of the catheter and is doing well.

• Brand Name: IAB : 8 FR - 40 CC FOS
• 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: 5104561
• MDR Text Key: 26780288
• Report Number: 1219856-2015-00203
• 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: Biomedical Engineer
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F15G0028
• Other Device ID Number: 00801902007247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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 Outcome(s): Required Intervention