MAUDE Adverse Event Report: COOPERSURGICAL INC. FETAL PILLOW, BOX OF 6

Model Number FP-010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fetal Distress (1856); Hemorrhage/Bleeding (1888); Scar Tissue (2060); Uterine Perforation (2121); Rupture (2208); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc is currently investigating the reported condition.

Event Description

Incident detail- hope you are well, you might be aware of this report from (b)(6) of a posterior uterine rupture in a patient where fetal pillow was used.(b)(6) has used (b)(6) translate that is somewhat amusing but my understanding from the translation is as follows: case details: it was a twin pregnancy in a primip who was induced at 39 weeks and labour was augmented and vacuum was attempted in the first twin for fetal distress that failed and a cs was carried out when a posterior uterine rupture was found, there was intrapartum haemorrhage and baby was in poor condition according them but seemed to have reasonably good apgars 5/1,7/5 and 10/10 mins.Mother had difficult procedure as one would expect and a slow post operative recovery (they have not detailed the problems).Additional information- uterine rupture during labour is uncommon but well-documented complication, and the majority of cases occur in women with scarred uteri.Posterior wall rupture is even less common but there are a few case reports in the literature.The scarred uterine ruptures are often secondary to previous caesarean sections, salpingectomy with cornual resection, deep cornual resection, myomectomy, iatrogenic uterine perforation, or less commonly to placenta increta, congenital anomalies, trauma and sacculation of entrapped retroverted uterus (arbab et al., 1996; bretones et al., 1997; elsayegh and nwosu, 1998; imseis et al., 1998).There are few important details missing from this that would have been helpful, labour was induced in this patient (a known factor in spontaneous rupture of unscarred uterus).Length of labour and that of second stage is not known and we do not know if this patient had previous gynaecological surgery.Most importantly fetal pillow is not indicated for twin pregnancy, fetal pillow has been used in over 50,000 full dilation cs in singleton pregnancies and to our knowledge there have been no reported cases of uterine rupture during fp fetal pillow box of 6 fp-010 e-complaint- (b)(4).

Manufacturer Narrative

Investigation x-no sample returned x-inspect stock product analysis and findings distribution history, the complaint product was manufactured under lot#20587.Manufacturing record review a review of the device history record could not be performed as the record could not be located at the time of this investigation.However, it should be noted at the time of manufacture records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Should the device history record be located going forward, it will be reviewed, & this complaint amended accordingly.Incoming inspection review non-rout insp-21-06-23-001 was reviewed & no non-conformities, related to the complaint condition, were noted.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show similar reported complaint conditions.Product receipt the complaint product has not been returned to coopersurgical.Visual evaluation evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated & any findings will be appended to this investigation.Functional evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated & any findings will be appended to this investigation.Root cause a sampling visual inspection was conducted on the reported lot number remaining in finished goods (c=0, aql=2.5) & no discrepancies were found.Also, referencing the ifu (see attachment), there is a warning stating "the safety and effectiveness of fetal pillow has not been established in the following: [?]10.Multiple gestations".The reported complaint states this was a twin pregnancy.Root cause not applicable as the complaint was not confirmed.Correction and/or corrective action no further corrective action is necessary, as the complaint condition was not confirmed.No training required at this time.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

Event Description

Incident detail- hope you are well, you might be aware of this report from denmark of a posterior uterine rupture in a patient where fetal pillow was used.Innes has used google translate that is somewhat amusing but my understanding from the translation is as follows: case details it was a twin pregnancy in a primip who was induced at 39 weeks and labour was augmented and vacuum was attempted in the first twin for fetal distress that failed and a cs was carried out when a posterior uterine rupture was found, there was intrapartum haemorrhage and baby was in poor condition according them but seemed to have reasonably good apgars 5/1,7/5 and 10/10 mins.Mother had difficult procedure as one would expect and a slow post operative recovery (they have not detailed the problems).Additional information- uterine rupture during labour is uncommon but well-documented complication, and the majority of cases occur in women with scarred uteri.Posterior wall rupture is even less common but there are a few case reports in the literature (see attached).The scarred uterine ruptures are often secondary to previous caesarean sections, salpingectomy with cornual resection, deep cornual resection, myomectomy, iatrogenic uterine perforation, or less commonly to placenta increta, congenital anomalies, trauma and sacculation of entrapped retroverted uterus (arbab et al., 1996; bretones et al., 1997; elsayegh and nwosu, 1998; imseis et al., 1998).There are few important details missing from this that would have been helpful, labour was induced in this patient (a known factor in spontaneous rupture of unscarred uterus).Length of labour and that of second stage is not known and we do not know if this patient had previous gynaecological surgery.Most importantly fetal pillow is not indicated for twin pregnancy, fetal pillow has been used in over 50,000 full dilation cs in singleton pregnancies and to our knowledge there have been no reported cases of uterine rupture during fp.1216677-2021-00168 fetal pillow box of 6 fp-010 e-complaint-(b)(4).

• Brand Name: FETAL PILLOW, BOX OF 6
• Type of Device: FETAL PILLOW
• Manufacturer (Section D): COOPERSURGICAL INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 12336370
• MDR Text Key: 268707204
• Report Number: 1216677-2021-00168
• Device Sequence Number: 1
• Product Code: PWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN150053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FP-010
• Device Catalogue Number: FP-010
• Device Lot Number: 20587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other