MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. IAB : 8 FR - 30 CC FOS; INTRA- AORTIC BALLOON LWS CATHETER

Catalog Number IAB-05830-LWS

Device Problems Occlusion Within Device (1423); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2015

Event Type  malfunction  

Event Description

It was reported that the (iab) intra- aortic balloon catheter was inserted proactively for support during (pci) percutaneous coronary intervention in the (ccl) cardiac catheter lab.The (rn) registered nurse stated, the iab was correctly zeroed and calibrated with iab remaining in catheter tray until fos zeroed, audible and visual alerts for completion of fos zero procedure and green bulb.The iab zeroed prior to insertion was present, and confirmed by both scrub rn and scout rn.No complications at this point with fos set up.The iab was then carefully removed from catheter tray and prepped as per ifu instructions, and as per intensive iab set up training that was given to the whole nursing department by teleflex academy staff three days prior.The scrub nurse reported removing stylet and flushing iab once removed from catheter tray and handed to cardiologist for left femoral sheathed iab insertion.At this point, the icon is green bulb on the pump s/n (b)(4).The iab was then inserted by consultant cardiologist, during which the scrub nurse noted the cardiologist did not rotate catheter on insertion.At the point of inserting iab into patient the circulating nurse reported the green bulb fos indicator turned to a black bulb (fiberopix iab not connected).The cardiologist was unable to aspirate from the central lumen.Counterpulsation was not commenced and the decision was made to do a guidewire iab exchange for new fos catheter.The rn's reported the cardiologist removed fos catheter by pulling through the sheath without complications.The circulating rn then opened new 40cc fos catheter the second iab was prepped and inserted counterpulsation was commenced and patient proceeded to have pci procedure and was transferred to icu with counterpulsation therapy continuing.Patient outcome was reported to be stable throughout catheter exchange.There was a reported delay / interruption in iabp therapy; however no harm to the patient was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Device evaluation: returned for evaluation was a 30cc 8.0fr fos iab.The bladder membrane was fully unwrapped upon return.No blood was noted on the outside or inside of the bladder membrane.No damage, kinks, or abnormalities were noted with the catheter.The fos connector and cal key were examined.The gray fos connector was recessed 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 cal key and fos were connected to the iabp.The cal key was recognized.The fos was not recognized because of the recessed fos connector.Using lab inventory forceps, the gray fos connector was held in place and the fos was recognized by the iabp.The fos displayed an "ok" status.A 0.025 inch spring wire guide (swg) was front loaded through the luer end of the iab.No resistance was encountered; the swg was able to advance.The swg was back loaded through the iab distal tip.No resistance was encountered; the swg was able to advance.No blood or debris exited with the swg.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 iab was submerged in water and leak tested.The unit passed leak test.No holes or leaks were noted on the bladder membrane.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 signal was lost is confirmed.The fos was returned with a recessed connector; therefore, a light path could not be established between the sensor and the pump.The fiber was found intact and functional.The root cause of the recessed fos is undetermined.

Event Description

It was reported that the (iab) intra- aortic balloon catheter was inserted proactively for support during (pci) percutaneous coronary intervention in the (ccl) cardiac catheter lab.The (rn) registered nurse stated, the iab was correctly zeroed and calibrated with iab remaining in catheter tray until fos zeroed, audible and visual alerts for completion of fos zero procedure and green bulb.The iab zeroed prior to insertion was present, and confirmed by both scrub rn and scout rn.No complications at this point with fos set up.The iab was then carefully removed from catheter tray and prepped as per ifu instructions, and as per intensive iab set up training that was given to the whole nursing department by teleflex academy staff three days prior.The scrub nurse reported removing stylet and flushing iab once removed from catheter tray and handed to cardiologist for left femoral sheathed iab insertion.At this point, the icon is green bulb on the pump s/n (b)(4).The iab was then inserted by consultant cardiologist, during which the scrub nurse noted the cardiologist did not rotate catheter on insertion.At the point of inserting iab into patient the circulating nurse reported the green bulb fos indicator turned to a black bulb (fiberopix iab not connected).The cardiologist was unable to aspirate from the central lumen.Counterpulsation was not commenced and the decision was made to do a guidewire iab exchange for new fos catheter.The rn's reported the cardiologist removed fos catheter by pulling through the sheath without complications.The circulating rn then opened new 40cc fos catheter the second iab was prepped and inserted counterpulsation was commenced and patient proceeded to have pci procedure and was transferred to icu with counterpulsation therapy continuing.Patient outcome was reported to be stable throughout catheter exchange.There was a reported delay / interruption in iabp therapy; however no harm to the patient was reported.

• Brand Name: IAB : 8 FR - 30 CC FOS
• Type of Device: INTRA- AORTIC BALLOON LWS CATHETER
• 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: 4964110
• MDR Text Key: 22023971
• Report Number: 1219856-2015-00161
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,for
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2015

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: 01/31/2016
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18F14A0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2014
• 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